Portable drug mixing and delivery device and associated methods

ABSTRACT

A telescoping portable drug mixing and delivery device configured to store a dry medication separately from a liquid component, wherein a tensile force applied between the housing and a cap opens a valve and causes displacement of a fluid from a first chamber to a second chamber while simultaneously mixing the fluid with a dry medicament prior to injection. An extendable needle guard is provided over the delivery assembly which prevents premature injection as well as inadvertent sticks or other cross contamination of a needle. The needle guard can also form part of a secondary trigger mechanism which injects the reconstituted drug after the mixing stage is complete.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of each of the followingapplications: U.S. patent application No. 62/061,664 filed on Oct. 8,2014; and U.S. patent application Ser. No. 14/218,355 filed on Mar. 18,2014 which also claims benefit to U.S. patent application No. 61/800,014which was filed on Mar. 15, 2013, as well as U.S. application No.61/917,943 which was filed Dec. 19, 2013 which are all hereinincorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to auto-injectors and prefilledsyringes and more particularly to auto-injectors that store in a compactstate and allow for formation or reconstitution of a therapeutic agentfor injection.

BACKGROUND OF THE INVENTION

Individuals who suffer from certain medical conditions are oftenrequired to keep an auto-injector or prefilled syringe nearby in orderto address a medical need. A few examples of this are insulin pens forpeople with diabetes, epinephrine for those with food and insect stingsallergies, and antidotes for soldiers at risk of exposure to chemicaland/or biological toxins in the field. For example, an allergic reactionmay occur in a location which is physically distant from the nearesthospital or medical facility. For example, bee stings, are more likelyto occur outside than indoors. Food containing peanuts are more likelyto be supplied to the individual away from a controlled home environmentlike at a baseball park. Having a portable epinephrine auto-injectornearby enables emergency intervention after an exposure to an allergen.

Size is an issue when it comes to auto-injectors. Many owners of thedevices are hesitant to carry their injector with them if it representsa burden, by providing injectors in more compact sizes it will make itmore likely that they will.

Shelf-life is also a large issue with respect to auto-injectors, whichcan be expensive and used fairly infrequently. For example a user whohas intense allergic reactions to shellfish can go years betweenexposures and subsequent injections. In such a case it can be easy toforget to replace the auto-injector after expiration, whereupon in anemergency, the drugs contained therein have expired and are eitherineffective or have a greatly reduced effectiveness due to decompositionof the drugs contained therein. As will be appreciated by those havingskill in the art, the shelf life can be increased by storing the desiredmedication in an unmixed and dry state and dissolved just prior toinjection. This ability to store the wet and dry components separatelywithin the device can increase the shelf life and thus increase thelikelihood that the user will have an injector with effective dosageswhen an emergency arises.

In such devices it is required that the mixing and reconstitutionprocesses are consistent and complete prior to injection.

SUMMARY OF THE INVENTION

It has been recognized that if a drug can be kept out of the liquidphase and stored as a dry medication, the shelf-life can be increasedsubstantially while temperature susceptibility can be decreasedsubstantially, thus allowing the efficacy and potency of the drug toendure longer and through harsher environments.

It has been recognized that a smaller drug delivery device than aconventional epinephrine auto-injector, which could be attached to a keychain and/or easily fit in a person's pocket, would make the deviceeasier to carry and more likely that the user will have it on theirperson when needed. Various structures are contemplated herein, whichaddress many of the problems discussed above through the use of mixingstructures, and actuation devices, which ensure proper storageintegrity, and full mixing prior to injection.

Contemplated herein is a medication mixing and delivery device, Amedication mixing and delivery device which includes a housing whichcontains a first chamber, a second chamber, and a compression chamberlocated within the housing, wherein each chamber has a selectivelychangeable effective volume. A fluidic channel can be provided anddisposed between the first and second chambers as well as a seal whichcan be positioned between the first chamber and the compression chamber.In addition, a movable body can be provided which is disposed betweenthe first and second chamber.

A mixing actuation device can then be coupled to the movable body,wherein activation of the mixing actuation device facilitates theselective reduction of the effective volume of the first chamber, theselective reduction of the effective volume of the compression chamber,and displacement of a liquid stored in the first chamber from the firstchamber into the second chamber via the fluidic channel.

Further, a delivery assembly can be provided in fluid communication withthe second chamber and which facilitates delivery to the user, such asthrough a needle to an injection site.

In some embodiments a dry medicament can be provided within the housingand outside the first chamber such as in the fluidic channel or withinthe second chamber.

In yet additional embodiments the drug mixing and delivery device caninclude a fluidic bypass formed in a sidewall of the first chamber. Insome such embodiments the the fluidic channel can be provided throughthe movable body and is selectively placed into fluidic communicationwith the fluidic bypass upon translation of a mixing displacementmechanism, i.e. a plunger which can be affixed to the movable body.

In yet additional embodiments the seal can be provided as a dynamic sealwhich is configured to flex or translate axially.

In yet other embodiments a mixing displacement device can be coupled tothe movable body, wherein the mixing actuation device is activatedthrough application of an axial tensile force, which axial tensile forcereleases a stop and allows the movable body and mixing displacementmechanism to translate in a first direction.

In yet additional embodiments an intermediate stopping mechanism can beprovided wherein the intermediate stopping mechanism prevents fluidcommunication from the second chamber to the delivery assembly prior toactivating a delivery actuation device.

In some of the embodiments shown herein the drug mixing and deliverydevice of can further include two independent and directionally opposingsprings, wherein one spring is a mixing spring that is coupled to themixing actuation device and upon triggering the mixing actuation devicereleases energy from the mixing spring that directs the movable body ina first direction, and wherein the other spring is a delivery springthat is coupled to a delivery actuation device and upon triggering thedelivery actuation device releases energy that directs the movable bodyin a second direction.

In yet additional embodiments the medication mixing and delivery devicecan also include a needle shield assembly, the needle shield assemblyhaving a needle shield and a needle shield spring, the needle shieldspring biasing the needle shield in an extended position. In some suchembodiments the needle shield forms a part of the delivery actuationdevice, the delivery actuation device being configured to displace themovable body downward so as to displace the fluid out of the secondchamber through the delivery assembly, and whereupon depressing theneedle shield toward the housing triggers actuation of the deliveryactuation device.

In additional embodiments the needle shield assembly further includes alocking mechanism, which is triggered after a first needle shielddepression, and wherein the locking mechanism is configured to lock theneedle shield in an extended position after being removed from aninjection site.

In yet additional embodiments an additional delivery actuation devicecan be provided which is also coupled to a delivery spring that, uponactivating, the delivery actuation device causes energy from thedelivery spring to be released and cause the movable body, which iscoupled to a delivery displacement mechanism, to translate in anopposite direction of the movement initially facilitated by the mixingactuation device, thus facilitating displacement of liquid transferredto the second chamber from the first chamber to be displaced through thedelivery assembly.

In some embodiments the compression chamber can contain a gas and thechamber is configured to vent the gas upon activating the mixingactuation device, wherein the volume of gas contained therein isdisplaced in part by the dynamic seal.

In yet additional embodiments the mixing and delivery device can includea delivery actuation device, and wherein the mixing actuation device andthe delivery actuation device are each coupled to a multi-cam system. Insome such embodiments the multi-cam system can include a plurality ofcamming features, ramps, etc.

In yet additional embodiments the medication mixing and delivery devicecan include a mixing spring coupled to the mixing actuation device,wherein the mixing spring is initially stored in torsion andcompression, and whereupon activating the mixing actuation devicereleases the a torsional force and an extension force of the spring. Insome such embodiments the mixing spring can be re-torqued prior toactivating the delivery actuation device, wherein the torque released isdirected to and rotates the movable body about an axis.

In yet other embodiments a method for mixing and delivering a medicationis contemplated wherein the steps of the method can include: activatinga mixing actuation device of a medication mixing and delivery devicethat translates a movable body, wherein the medication mixing anddelivery device includes: a housing; a first chamber, a second chamberand a compression chamber located within the housing, wherein eachchamber has a selectively changeable effective volume; a fluidic channeldisposed between the first and second chambers; a seal positionedbetween the first chamber and the compression chamber; the movable bodydisposed between the first and second chamber, the movable body beingcoupled to a mixing displacement mechanism; the mixing actuation devicecoupled to the movable body; and a delivery assembly configured to be influid communication with the second chamber;

displacing the effective volume of the compression chamber by causingthe mixing displacement mechanism coupled to the movable body totranslate toward the dynamic seal; displacing a liquid stored in thefirst chamber through the fluidic channel into the second chamber; anddisplacing the liquid now stowed in the second chamber through thedelivery device.

In additional embodiments the method can further include the step ofreleasing a torsional and compression force stored in a mixing springthat is coupled to the mixing actuation device, wherein the compressionforce from the mixing spring provides energy for the movable body totranslate toward the seal, wherein the released torsional force acts onand causes the movable body to rotate about an axis.

In additional embodiments the method can further include the step ofarming a delivery actuation device upon activation of the firstactuation device by re-torqueing the mixing spring prior to displacingthe liquid now stowed in the second chamber.

In additional embodiments the method can further include the step ofactivating the delivery actuation device that is coupled to a deliveryspring, whereupon activation of the delivery actuation device releasesenergy stored in the delivery spring and causes the movable body, whichis coupled to delivery displacement device, to translate towards thesecond chamber and displace a liquid that was previously displaced fromthe first chamber through the delivery assembly.

In additional embodiments the method can further include the step ofmixing the liquid with a dry medicament stored in the housing outside ofthe first chamber prior to displacing the now mixed liquid through thedelivery assembly.

In additional embodiments the method can further include the step ofactivating the mixing actuation device step by pulling an extensiontrigger that releases a stop thereby allowing energy stored in a mixingspring to be released.

In additional embodiments the step of displacing an effective volumefrom the compression results in either a gas stored in the compressionchamber to be compressed or vented out through a vent.

In yet additional embodiments a medication mixing and delivery device iscontemplated which includes a housing; a compression chamber locatedwithin the housing and having a dynamic seal about one end; a firstchamber located within the housing proximal a first end, wherein thefirst chamber further includes: an effective volume defined between afirst displacement mechanism and the dynamic seal, the firstdisplacement mechanism being configured to selectively reduce theeffective volume of the first chamber; a fluidic bypass provided in asidewall being configured to selectively bypass the first displacementmechanism; a second chamber located within the housing configured toreceive a volume of liquid being displaced from the first chamber by thefirst displacement mechanism, the second chamber having an effectivevolume defined between a second displacement mechanism and an opposingwall; a movable body disposed between the first and second chamber, themovable body further being coupled to the first and second displacementmechanism; a mixing actuation device coupled to the movable body,wherein activation of the mixing actuation device displaces the movablebody in a first direction which displacement causes the firstdisplacement mechanism to reduce the effective volume of the firstchamber; a delivery assembly configured to be in fluid communicationwith the second chamber; and a delivery actuation device coupled to asecond trigger, wherein activation of the delivery actuation devicedisplaces the movable body in a second direction which displacementcauses the second displacement mechanism to reduce the effective volumeof the second chamber.

The second direction some instances is opposite of that of the firstdirection and in other instances it is in a direction that is differentthan the first direction.

In some such embodiments the mixing actuation device can be activatedthrough application of an axial tensile force, which axial tensile forceis configured to release a first stop of the mixing actuation device andallows the movable body and first displacement mechanism to displace inthe first direction, establish fluidic communication between the firstand second chambers, and thus displace a liquid component from the firstchamber, through at least the fluidic bypass, and into the secondchamber.

In yet additional embodiments a medication mixing and delivery device iscontemplated which includes: a housing having a chamber, wherein amedicament is stored therein; a needle shield assembly that is coupledto a first actuation device, wherein the needle shield assembly iscomprised of a needle shield and a pre-stored energy source, wherein theneedle shield is initially positioned in a stowed state prior toactivating the first actuation device, which first actuation devicecauses a first portion of the needle shield to extend indicating a readystate; a second actuation device coupled to the needle shield assembly,wherein the extended first portion functions as a trigger for the secondactuation device and upon depressing the first portion activates thesecond actuation device; and a delivery assembly configured to be influid communication with the chamber.

In some such embodiments activating the delivery actuation device cancause or establish fluidic communication between the chamber and thedelivery mechanism, and further releases a locking mechanism thatreleases energy stored in the pre-stored energy source that directs theneedle shield to extend to a position beyond that of the deliveryassembly.

In yet additional embodiments a medication mixing and delivery device iscontemplated which includes: a housing; a first chamber and a secondchamber located within the housing, wherein each chamber has aselectively changeable effective volume; a fluidic channel disposedbetween the first and second chambers; a movable body disposed betweenthe first and second chamber; a mixing actuation assembly coupled to themovable body and a mixing spring, wherein activation of the actuationdevice facilitates the rotation and translation of the movable bodyabout an axis, the selective reduction of the effective volume of thefirst chamber, and a transferring of liquid stored in the first chamberto be displaced from the first chamber and enter into the second chambervia the fluidic channel. This embodiment can further include a deliveryassembly configured to be in fluid communication with the secondchamber.

In some such embodiments the medication mixing and delivery device canfurther include a torqueing component configured to cause torsion in themixing spring during the actuation of the mixing actuation assembly.

In some such embodiments the medication mixing and delivery device canfurther include a compression chamber separated from the first chamberby a dynamic seal.

In some such embodiments the medication mixing and delivery device canfurther include a delivery actuation assembly configured to transferfluid from the second chamber through the delivery assembly.

In some such embodiments the delivery actuation can be coupled to anextendable trigger, whereupon triggering the extendable trigger causesthe delivery actuation assembly to actuate wherein the mixing actuationassembly is coupled to the extendable trigger, and causes a portion ofthe extendable trigger to be extended during actuation of the mixingactuation assembly and wherein triggering the extendable trigger causesthe mixing spring to release a torsional force.

In some such embodiments depressing of the extendable trigger can causeenergy from a pre-loaded needle assembly energy source to be releasedthat extends a portion of the needle shield assembly to extend beyondthe delivery assembly. In some such embodiments a locking mechanism canbe provided that prevents the extended needle shield assembly fromretracting after being extended beyond the delivery assembly.

In some additional embodiments, the medication mixing and deliverydevice can further include a torqueing component in the form of amulti-cam system.

In yet additional embodiments a method for mixing and delivering amedication, the method is contemplated which involves various steps,such steps including: releasing energy stored in a pre-torqued andpre-compressed mixing spring, wherein the release of energy causes amovable body, disposed between a first and second chamber disposed inthe housing of a mixing device, to rotate and translate about an axis;displacing an effective volume of the first chamber with a displacementdevice coupled to the movable body; transferring a fluid stored in thefirst chamber through a fluidic channel to the second chamber;re-torqueing the mixing spring; releasing energy from the re-torquedspring that causes the movable body to rotate again; transferring fluidfrom a second chamber through a delivery assembly.

This method can further include providing a delivery system coupled tothe mixing device, wherein the delivery system includes a deliveryactuation assembly coupled to the movable body.

This method can further include extending a trigger coupled to thedelivery actuation assembly; activating a trigger coupled to thedelivery actuation assembly; and depressing the trigger, whereby energyis released from a delivery spring that causes the delivery actuationdevice to translate the movable body.

In yet additional embodiments a medication mixing and delivery device iscontemplated which includes: a housing having a first chamber and asecond chamber with selectively variable effective volumes; a first andsecond displacement component mechanically coupled to a multi-camsystem; a pre-loaded energy source coupled to the multi-cam system; afirst and second trigger coupled to the multi-cam system, whereintriggering the first trigger causes energy to be released from thepre-stored energy and direct the first displacement component todisplace a liquid stored in the first chamber through a fluidic channelinto the second chamber, and wherein triggering the second triggerreleases additional energy that directs the second displacementcomponent to displace liquid now stored in the second chamber to bedisplaced and exit through a delivery assembly that is in fluidcommunication with the second chamber.

In some such devices the multi-cam system can include a three-camcomponent. Additionally some such devices a mixing spring and a deliveryspring which function as pre-loaded energy sources for driving thevarious steps or moving into the various states.

In yet additional embodiments the medication and delivery device canfurther include a movable body disposed between the first and secondchambers, wherein the movable body is coupled to the multi-cam systemand is configured to rotate and translate about an axis.

In yet additional embodiments the medication and delivery device aneedle shield assembly can be incorporated into the second trigger,wherein the multi-cam system allows the second trigger to partiallyextend upon release of energy from the pre-loaded energy source. In somesuch embodiments the needle shield of the needle shield assembly can beconfigured to extend beyond the delivery assembly upon depressing thesecond trigger.

In yet another embodiment a medication and delivery device comprises ahousing having a first chamber and a second chamber with selectivelyvariable effective volumes; a first and second displacement componentcoupled to a single actuation assembly that is coupled to a first andsecond spring, wherein actuating the actuation assembly a first timereleases energy stored in the first spring that drives the firstdisplacement component in a first direction, and wherein actuating theactuation assembly a second time releases energy stored in the secondspring that drives the second displacement component in a seconddirection that is different that the first direction, wherein the firstactuation causes liquid to transfer from the first chamber to the secondchamber, and wherein the second actuation causes fluid to transfer fromthe second chamber through a delivery assembly.

Alternative methods can include various manufacturing and assembly stepsfor a mixing and delivering device, such methods including various stepssuch as: providing a needle shield; extending the needle shield inresponse to the mixing actuation, wherein a subsequent depression of theneedle shield causes initiates the delivery actuation.

These aspects of the invention are not meant to be exclusive and otherfeatures, aspects, and advantages of the present invention will bereadily apparent to those of ordinary skill in the art when read inconjunction with the following description, appended claims, andaccompanying drawings. Further, it will be appreciated that any of thevarious features, structures, steps, or other aspects discussed hereinare for purposes of illustration only, any of which can be applied inany combination with any such features as discussed in alternativeembodiments, as appropriate.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features, and advantages of theinvention will be apparent from the following description of particularembodiments of the invention, as illustrated in the accompanyingdrawings in which like reference characters refer to the same partsthroughout the different views. The drawings are not necessarily toscale, emphasis instead being placed upon illustrating the principles ofthe invention, wherein:

FIGS. 1A-E illustrate a portable drug mixing and delivery device inaccordance with various aspects of the present invention;

FIGS. 2A-E illustrate another portable drug mixing and delivery devicein accordance with additional aspects of the present invention;

FIG. 3 illustrates an exploded view of the portable drug mixing anddelivery devices illustrated in FIGS. 2A-E;

FIGS. 4A-F illustrate various cross sectional views of a portable drugmixing and delivery device in accordance with the embodiments of eitherFIGS. 1A-E or FIGS. 2A-E;

FIGS. 5A-D illustrate a mixing assembly for use in either of theportable drug mixing and delivery devices illustrated in FIGS. 1A-E orFIGS. 2A-E;

FIGS. 6A-F illustrate various stages of a mixing mechanism and processwhich is applicable to either of the portable drug mixing and deliverydevices illustrated in FIGS. 1A-E or FIGS. 2A-E;

FIGS. 7A-G illustrate various stages of an arming and needle shieldextension mechanism and process which is applicable to either of theportable drug mixing and delivery devices illustrated in FIGS. 1A-E orFIGS. 2A-E;

FIGS. 8A-B illustrate various front and side views of a movable body andan associated cam ring mechanism for use in either of the portable drugmixing and delivery devices illustrated in FIGS. 1A-E or FIGS. 2A-E;

FIGS. 9A-B illustrate various perspective and cross sectional views of aneedle shield for use in either of the portable drug mixing and deliverydevices illustrated in FIGS. 1A-E or FIGS. 2A-E;

FIGS. 10A-D illustrate various stages of a firing mechanism and processwhich is applicable to either of the portable drug mixing and deliverydevices illustrated in FIGS. 1A-E or FIGS. 2A-E;

FIG. 11 illustrates a fluidic channel insert which is adaptable for usein either of the portable drug mixing and delivery devices illustratedin FIGS. 1A-E or FIGS. 2A-E;

FIGS. 12A-B illustrate exploded perspective views of yet anotherembodiment of a portable drug mixing and delivery device in accordancewith various aspects of the present invention as well as a mixingassembly for use therein;

FIGS. 13A-C illustrate partial perspective cut away views of theportable drug mixing and delivery device of embodiment of FIGS. 12A-Bwhich illustrate various mixing actuation steps which further illustratevarious aspects of the present invention;

FIGS. 14A-C illustrate partial side cross-sectional views of theportable drug mixing and delivery device of embodiment of FIGS. 12A-Bwhich illustrate various mixing actuation steps which further illustratevarious aspects of the present invention;

FIGS. 15A-C illustrate partial side cross-sectional views of theportable drug mixing and delivery device of embodiment of FIGS. 12A-Bwhich illustrate various mixing actuation steps which further illustratevarious aspects of the present invention; and

FIGS. 16A-D illustrate partial side cut away views of the portable drugmixing and delivery device of embodiment of FIGS. 12A-B which illustratevarious injection actuation steps which further illustrate variousaspects of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

It will be appreciated by those having skill in the area of fabricationand storage of drugs, that the lifespan and effectiveness of the drugcan be increased substantially by keeping the medication in a dry state.Storage in a dry state also decreases the rate of degeneration as wellas the degenerative effects of temperature, for example heat exposure.By keeping the drug in a dry state the breadth of environments where thedevice can be stored is increased while decreasing the frequency ofrequired replacement.

The present invention illustrates various principles and devices whichallow for the storage of a device having two or more componentscontained therein but which can quickly and reliably reconstitute,dissolve, fluidize, and/or put into a suspension, the components, i.e.mix them, immediately prior to delivery.

As such, a system and method for storing and/or mixing a dry medicamentcomponent with a wet component for delivery to a user is contemplatedherein.

As illustrated in FIGS. 1A-E and FIGS. 2A-E. The system can include anauto-injector, 10 and 20, which illustrate a stowed state in FIGS. 1Aand 2A. The auto injector, 10 or 20, is activated by pulling orextending the device, which extension initiates and actuates a firstmixing step, as shown in FIGS. 1B and 2B. Once mixing is complete, aneedle shield is released and permitted to extend, as shown in FIGS. 1Cand 2C, wherein a subsequent re-depression of the needle shield operatesas a trigger for an injection step which operates to eject the needleand inject the mixed drug to an injection site, as shown in FIGS. 1D and2D.

As the auto injector device is pulled away from the injection site theneedle shield is automatically extended and locked into the extendedstate, blocking the needle, so as to minimize the visibility of theneedle pre and post injection, and thus prevent accidental sticks to theuser or others in the vicinity. A locking mechanism can thus be providedso as to lock the needle shield in the extended position. In oneembodiment the extended arms of the needle shield can be caused tointerfere with corresponding protrusions within the housing, oralternatively the needle shield can be provided with radially outwardbiased tabs which lock into a corresponding slot in the housing.

With reference to FIG. 3, shown is an exploded view of an auto injectorassembly 10 and internal mixing assembly 15, which illustrates thevarious individual components and will be helpful in explaining theinterplay between the various components below.

The auto injector assembly 10 can include an external housing 100. Aneedle shield 150 can have a needle shield spring 50 which can be biasedso as to extend the needle shield 150 axially with respect to thehousing 100 in a downward or injection direction. The upper end of thehousing can be provided with a hanger retention clip 72 and atelescoping component 130, wherein the telescoping component 130 can bepulled and extended with respect to the housing 100 so as to initiateand actuate a mixing step, which mixing step will be discussed in moredetail below.

The mixing assembly 15 can include a plurality of vials 200 and 400 witha movable body 300 disposed there between. The movable body 300 can havean actuation device in the form of a cam ring 350 disposed thereon,wherein the cam ring 350 facilitates movement of plungers 210 and 312into the first and second vials 200 and 400 respectively during mixingand subsequent injection steps. A mixing spring 40 can facilitate axialand rotational motion of certain steps of the cam ring 350 and aninjection spring 60 can facilitate downward axial displacement of theentire mixing assembly 15 during an injection step which can cause aninjection assembly to extend, i.e. the needle 410 to pierce the membrane412, wherein the mixed drug can then be ejected through the needle 410and into an injection site. The injection assembly 15 can furtherinclude a dynamic seal 250 and a vial sleeve 270 and a hanger 70 thatwill be discussed in greater detail below as they relate to the mixingand injection steps. Additionally the vial 200 can be provided with afluidic bypass 202 which structure and functionality will be discussedin more detail below.

With reference to FIGS. 4A-F and FIGS. 5A-D shown is an exemplaryembodiment of an auto-injector 10 and a mixing assembly 15 containedtherein in accordance with various aspects of the present inventionembodiment which illustrates various states through the actuation of theauto-injector from a stowed to an injected state.

The auto-injector 10 can include a housing 100 which houses a pluralityof vials 200 and 400, which can form first and second chambers 201 and401 respectively. The first chamber 201 can be defined as a spacebetween a first plunger 210 and a dynamic seal 250 within the first vial200. This first chamber 201 can be configured to initially hold a firstcomponent of an unmixed medicament. The second chamber 401 can bedefined as a space between a second plunger 312 and a bottom andside-walls of the second vial 400. This second chamber 401 can beconfigured to initially hold a second component of an unmixedmedicament. A fluidic channel 310 can be provided between the first andsecond chambers through a movable body 300, which separates the twochambers. The fluidic channel 310 can provide selective fluidiccommunication between the first and second chambers by means of axiallytranslating the movable body 300 with respect to the first vial 200,which will be discussed in more detail below.

In order to initiate change from a stowed state, as shown in FIG. 4A, toa mixed state, as shown in FIG. 4D, a telescoping component 130 can beextended with respect to the housing 100, the extension causing aportion of the telescoping component 130 to interact with variousactuating mechanisms of the movable body 300 causing it to translateaxially with respect to the first vial, establish fluidic communicationbetween the first and second chambers, and move the first plunger 210thus reducing the effective volume of the first chamber and displacingthe first component through the fluidic channel 310 and into the secondchamber 401. This displacement can cause the first component of themedicament to mix with the second component of the medicament, i.e. adry medicament, which second component can be stored within the fluidicchannel 310 or within the second vial 400 itself

In the embodiments shown the dry medicament can be contained within asecond chamber 401 or within a fluidic channel 310 which connects thetwo chambers, or within a recess formed at an opening or outlet thereofThe orientation of this embodiment includes a movable body 300 whichpushes a first plunger 210 or other displacement mechanism upwards intothe first chamber 201.

It will be appreciated that, with respect to gasses, most fluids areconsidered incompressible. In order to facilitate upward motion of thefirst plunger 210 or displacement mechanism, and the fluid containedwithin the first chamber 201, a third plunger or dynamic seal 250 and acompression chamber 252 can be provided wherein a compressible gas isprovided within the compression chamber 252 or the gas contained thereinis permitted to exit the compression chamber 252 freely. In someembodiments, as shown, the dynamic seal 250 can be provided as a movableplunger. In yet additional embodiments the dynamic seal can be providedas a flexible membrane that is allowed to stretch, deform, or otherwiseconform in response to an increase in pressure in the first chamber 201,so as to allow upward translation of the first displacement mechanism orplunger 210.

The upward translation of the first plunger 210 creates a pressure onthe incompressible fluid of the first medicament component which presseson the dynamic seal 250 or secondary movable wall, causing the dynamicseal to translate upward and allowing both the dynamic seal and thefirst plunger 210 to each translate upward in the direction of thecompression chamber 252 until a plunger channel 212 aligns with afluidic bypass channel 202 formed in a sidewall of the first vial 200.Once the plunger channel 212 is aligned, fluidic communication isestablished between the first chamber 201 and the second chamber 401 andthe fluid or first medicament component is permitted to be displacedthrough the plunger channel 212, through the fluidic channel 310, andinto the second chamber 401 as the first plunger 210, or otherdisplacement mechanism, reduces the effective volume of the firstchamber 201. It will be appreciated that the fluidic bypass channel 202is sufficient in length in an axial direction such that it cancircumvent the first plunger 210 along then entire length of upwardtravel of the first plunger 210 within the first vial 200 until theeffective volume of the first chamber is reduced to near zero by thefirst plunger being displaced upward by the movable body 300. In theembodiment shown, the plunger channel 212 can be provided as a radiallydisposed slot on its bottom surface so as to allow fluid to travel fromthe bypass channel 202 which is located about the perimeter of the firstvial 200, to the inlet of the fluidic channel 310, which is locatedabout a central portion of the movable body and into the second chamber401.

In the embodiment shown, as the movable body is displaced upward, andmixing is achieved through the displacement of the movable body in anupward axial direction with respect to the housing, which can befacilitated by a mixing spring 40, the upward motion of the movable body300 can effectuate the release of a stop, which will be discussed inmore detail below, which interferes with the extension of the needleshield 150. In this manner, the needle shield 150 can be extended andserve as a secondary trigger for triggering the device to move from themixed state to injected state. In the embodiments shown, the needleshield 150 can be provided with a needle shield spring 50 which caneffectuate such extension and arming of the second trigger step.

In reference to FIGS. 6A-F, shown is various stages of a mixingoperation and the associated actuation associated therewith. As shown inFIG. 6A, the auto injector 10 will be changed from a stowed state bypulling upward on a telescoping component 130 or in other words exertinga tensile force between the telescoping component 130 and the housing100. The application of this tensile force acts as a first triggermechanism and causing the telescoping component 130 to translate axiallywith respect to the housing. The telescoping component 130 includes oneor more extensions 134 which extend into the housing 100. The extensions134 then further include a protrusion 138, which engages and interactswith the cam ring 350 of the movable body. The cam ring 350 includes amixing cam ramp 354 wherein axial extension of the telescopingcomponent, causes an upward motion of the protrusion 138 which in turncauses a rotation of the cam ring 350 as well as the movable body 300.The cam ring 350 can then further include an inward radial protrusion352 which rests on a stop 274 of the vial sleeve 270 in a stowed state.The rotation imparted to the cam ring 350 by the protrusion 138 causesthe inward radial protrusion 352 to rotate off of the stop 274 and intoa channel 272 which allows for axial translation of the movable bodywith respect to the first vial and the vial sleeve 270. This radialtranslation can be effectuated by a biased mixing spring 40 which pushesthe movable body 300 upward upon rotation of the inward radialprotrusion 352 off of the stop 274 and into the channel 272.

In the embodiments shown, the drug delivery and mixing device 10 or 20can include a mixing spring 40 disposed between the movable body 300 andthe vial sleeve 270. This spring is initially biased so as to maintainthe inward protrusion 352 onto the stop ledge 274 so as to maintain thedevice in a locked and unmixed stowed state. Upon pulling of thetelescoping component 130 the torsional bias is overcome so as to rotatethe inward protrusion 352 from the ledge 274 and into the channel 272.At this point the cam ring 350 is allowed to translate upward. Thisupward translation allows a simultaneous release of the needle shield150, arming of a second trigger, and mixing of the various drugcomponents by displacing the contents of the first vial into the secondvial, as discussed above.

Now with reference to FIGS. 7A-G, shown is a partial perspective view ofan auto-injector 10 which illustrates a concurrent step of mixing andextending the needle shield 150. In the illustrated embodiments, theextension of the needle shield 150 also serves as an indicator that thedevice is armed, wherein the movable body 300 is extended completelyupward thus displacing the first component from the first chamber to thesecond chamber, which complete upward displacement simultaneously allowsfor extension of the needle shield thus signifying an injection-readystate.

In the stowed state, the cam ring 350 is initially in an interferenceposition with a one or more radially outward oriented protrusions 154provided on one or more arms of the needle shield which extends into thehousing 100. The housing has corresponding notches 104 provided in asidewall, which notches are configured to receive the one or moreoutward oriented protrusions 154 in a stowed state. In this stowedstate, the cam ring 350 abuts against the back side of the outwardoriented protrusions 154 which provides interference to, and thusprohibits the outward oriented protrusions 154 from deflecting inwardand allowing the needle shield 150 to be extended. However, by rotatingthe cam ring 350, as discussed above, by pulling the telescopingcomponent 130, as shown in FIG. 7A, the cam ring is then allowed totranslate upward, moving the movable body, and corresponding plungerinto the first chamber.

In the embodiment shown, the cam ring has a sufficient width such that,one the movable body is pushed completely upward, the lower edge of thecam ring then clears the upper edge of the extensions on which theoutward oriented pair of protrusions 154 resides, and the needle shieldspring 50 provides a requisite force to cause the inward deflection ofthe outward oriented pair of protrusions 154 and the outward orientedpair of protrusions 154 can slide downward in an extended position intoa lower slot 106 in the sidewall of the housing, as shown in FIG. 7E. Itwill be appreciated that the lower slot 106 is larger so as to allowdepression and extension into a locked outward position during theinjection step.

Further, the needle shield 150 can be provided with an upper armextension and hook 158 which initially interfere with one or morecorresponding protrusions 278 provided on the vial sleeve 270, whichinterference prevents the needle shield 150 from being extended prior tocompletion of the mixing step. The hook 158 can also be configured so asto interfere with an interior portion of the housing after injection, soas to prevent the needle shield from being fully removed from thehousing after injection and any potential contamination by the usedneedle thereafter.

Once the needle shield 150 is extended such that the outward orientedpair of protrusions 154 are pushed into the lower slot 106, a subsequentdepression of the needle shield is configured to function as a secondtrigger mechanism which triggers release of energy stored in aninjection spring, shown as spring 60 in FIG. 3, which actuation will bediscussed in further detail below.

In order to fully understand the actuation, reference will now be madeto FIGS. 8A-B which illustrate the various cam ramps of the cam ring 350which effectuates movement of the movable body 300. FIGS. 8A-Billustrate the mixing cam ramp 354, which interacts with the inwardprotrusion of the telescoping component as discussed above, so as toinitiate rotation, and thus mixing. The cam ring 350 is also providedwith an injection ramp 358 which facilitates a second counter rotationof the cam ring 350 in an injection step upon depression of the needleshield back into the housing after initial extension. It will beappreciated that initially the cam ring 350 and movable body 300 rotateindependently of the vial sleeve 270 and the first vial 200 in the firstmixing step, however, because the cam ring protrusion 352 slides intothe channel 272 of the vial sleeve, any further rotation causes rotationof both the vial sleeve and the movable body together because the camring protrusion 352 interferes with the sidewalls of the channel 272within a small tolerance as shown in FIG. 6F. Thus, rotation of the camring 350 in the second actuation or injection step causes rotation ofthe entire mixing assembly.

This second actuation rotation is effectuated by providing anotherradially inward oriented protrusion 162 on an inner surface of theneedle shield 150 which interacts with another cam ramp of the cam ring158 Upon completion of the mixing step, another secondary actuationoccurs upon completion, wherein the cam ring has moved sufficientlyupward such that the needle shield can be extended. In this extensionprocess a few simultaneous actions are occurring during the extension.One action is that a second cam ramp 357 engages with an inwardprotrusion 162 of the needle shield, the relative axial motion causesthe cam ring to simultaneously re-load a small amount of energy intotorsional component of the mixing spring 40, and as the inwardprotrusion travels past the cam ramp 357 and below the protrusionforming the second cam ramp 357, the spring is unloaded again thusbringing the drug mixing and delivery device into the armed and mixedstate by aligning the inward protrusion 162 with a bottom portion of theopposing cam ramp 358. At this point, the needle shield 150 acts as asecond trigger mechanism which can be depressed to initiate injection.The depression then causes the inward protrusion 162 to engage with camramp 358, on the opposing side of the same protrusion forming cam ramp357, so as to impart an opposing rotation to the mixing assembly andthus trigger injection which will be discussed in more detail below byreleasing the mixing assembly from a retaining hanger, which will bediscussed in more detail below.

As discussed above, a torsional force component of the mixing springwhich is released upon activation of the mixing step, allows the camring 350 to translate, and then realign for second trigger arming andsubsequent needle shield depression and injection. This alignment forceof the torsional component is configured to come to rest in an alignedposition between the radially inward oriented protrusions 162 and abottom portion of the injection cam ramp 358. In this manner, adepression of the needle shield 150 causes a counter rotation of themixing assembly, in particular with regard to the housing 100 and thehanger 70 supported thereby. As shown, an upper portion of the mixingassembly includes a keyed slot or hole 78 which is provided in anunaligned position with a keyed protrusion 74 of the hanger 70. Therotation of the mixing assembly, through depression of the needle shield150, causes the keyed slot 78 to move from an unaligned state, as shownin FIGS. 10A-C, into an aligned state as shown in FIG. 10D, wherein uponalignment, the injection spring 60 is allowed to release a portion ofenergy stored therein, forcing the mixing assembly to translate axiallydownward until the needle barrier 412 abuts a bottom portion of theneedle shield, and wherein the needle is translated out through andpiercing the barrier until it extends past the injection end of thedevice, and wherein the second vial 400 finally abuts a bottom portionof the needle shield wherein the downward force causes the secondplunger 312 to displace the mixed drug from the second vial and into theinjection site.

It will then be appreciated that the needle shield 150 is still biasedoutward and will automatically re-extend to cover the needle as thedevice is pulled away from the injection site. After injection iscompleted, the needle shield 150 can then be caused to disengage fromthe stops 278 of the mixing assembly and extend into a fully lockedoutward position.

FIG. 11 illustrates a fluidic channel insert 310 a which can include aplurality of internal raised features 311 a, In some embodiments thefluidic channel insert 310 a can be formed of opposing plates 308 a and309A wherein the raised features 311 a can be machined or otherwiseprovided through laser or chemical etching processes on the opposinginterior surfaces and then assembled to form a singular insert with acentral cavity having the features on the exterior surfaces afterassembly. This insert can then be provided into the movable body so asto provide a fluidic channel having the desired configuration of raisedfeatures therein. These features can be manipulated so as to providevarious flow characteristics, such as increased turbulence for purposesof reducing flow resistance, increasing flow speed, mixingcharacteristics, etc.

FIGS. 12 illustrate yet another embodiment of an auto injector 500 whichutilizes various aspects of the present invention. Similar to theembodiments discussed above, the auto injector 500 utilizes a movablebody which initially moves in an opposing direction to the injectiondirection, which motion is initiated by pulling on a telescoping end andaxially translating a telescoping component with respect to the autoinjector housing. Other similarities arise in the provision of a dynamicseal as well as a compression or squeeze chamber to allow upwardtranslation of a displacement device until fluidic communication isestablished between separate and distinct chambers within the autoinjector.

In this embodiment the auto injector 500 is provided with drug mixingassembly 550, the mixing assembly 550 has a movable body in fluidcommunication with a first and second chamber. The first chamber orupper vial 618 can be configured to store a wet component. The mixingassembly can then be provided with an actuation device configured tocause the movable body 609 to enter a portion of the first chamber 618during a first actuation process thus displacing the wet componentstored therein into a second chamber or vial 614 during a secondactuation process. As the movable body 609 enters the first chamber 618,it displaces the wet component through a fluidic channel 621 providedwithin the movable body 609, and into the lower or second vial 614. Insome embodiments a dry powdered material containing at least onepharmaceutically active ingredient can be stored either in the fluidicchannel or within the second vial. In some configurations the fluidicchannel can effectively function as a third dry chamber wherein thefirst vial, the dry chamber, and the lower vial combine to form a totalof three chambers.

In one embodiment, fluidic communication can be enabled with the firstchamber and the dry chamber through a valve, burst membrane, orifice orother mechanism and/or opening. As illustrated, the aperture of thefluidic channel is initially sealed against the upper seal 610 thuspreventing premature mixing of the wet and dry components but thetranslation of the movable body 609 into a portion of the first chambercauses an aperture of the fluidic channel to translate sufficientlyupward so as to establish fluid communication, i.e. thus opening avalve. Once fluidic communication is established the wet componentstored in the first chamber 618 is permitted to flow through the fluidicchannel 621 and into the second or lower vial 614, and cause the drymedicament to combine and mix with the wet component as it flows intothe second or lower vial.

In a second motion and/or actuation step, the mixing assembly 550 isdriven downward, which motion then causes the movable body 609 totranslate into the second chamber 614 and subsequently displace themixed component through a delivery assembly, such as through a needle623 or jet (needle-less system) and into an injection site or otherdelivery site.

In some embodiments of the drug mixing system, the movable body 609 canbe provided with a mixing volume for retaining a dry medicamentcomponent. This mixing volume can be a dry chamber, a dry channel, or aseparate mixing chamber.

In yet additional embodiments of the drug mixing system, the volume ofthe movable body includes a separate fluidic channel assembly 621. Insome such embodiments the fluidic channel can be provided with internalfeatures designed to promote mixing. In yet additional embodiments, thefluidic channel is a micro-fluidic channel. In some such embodiments,the fluidic channel can be provided with tortious path having numerousbends. In yet further embodiments, the fluidic channel defines a volumefor mixing the wet component with the dry medicament. In yet additionalembodiments, the tortious path creates turbulent flow for mixing the wetcomponent with the dry medicament. In some such embodiments, the seriesof structures, walls, or grooves in the walls of the mixer body and orchannel can help promote mixing of the dry medicament and defining thevolume for mixing the wet component with the dry medicament.

In some such embodiments, at least one of the dimensions in the channelis less than 5 mm. In an embodiment, at least one of the dimensions inthe channel is less than 2 millimeters. In an embodiment, at least oneof the dimensions in the channel is less than 1 millimeters. In anembodiment, at least one of the dimensions in the channel is less than0.5 millimeters. In an embodiment, at least one of the dimensions in thechannel is less than 0.25 millimeters. In an embodiment, at least one ofthe dimensions in the channel is less than 0.1 millimeters. In anembodiment, at least one of the dimensions in the channel is less than0.05 millimeters. In an embodiment, the Reynolds number in the fluidicchannel is less than 2300, In an embodiment, the Reynolds number of thefluidic channel is less than 100, In an embodiment the Reynolds numberin the fluidic channel is 2300 or greater. In an embodiment, the channelfurther includes a plurality of grooves formed therein, wherein thegrooves promote mixing when a wet component flows by and/or near thegrooves. In an embodiment the mixing assembly further includes bends inthe channel wherein the bends promote mixing when a wet component flowsby the bends. In an embodiment, the mixing assembly includesobstructions in the flow path wherein said obstructions promote mixingwhen the wet component flows by the obstructions.

In one drug mixing system a powdered material or medicament can beloaded into a fluidic channel 621. In another drug mixing system apowdered material is loaded into a ferrule 625. In one embodiment thisferrule 625 is designed as an integrated feature inside the fluidicchannel 621, while in other configurations the ferrule 625 is positionedadjacent the fluidic channel 621. Powder or medicament can be filleddirectly into the ferrule 625 using several methods including vibrationtechniques, auger, volumetric fill, or, lyophilizing, spray drying,vacuum drying or filling of pellets, or other method of filling powderdoses. This ferrule 625 can be made of plastic, and/or rubber, and/orglass and/or any other suitable material. In another embodiment, theferrule 625 can be provided as a removable piece that can be filledoutside the fluidic channel using a variety of volumetrically dosing ormass based powder-dosing tools. Once the ferrule 625 is filled withpowder, separate from the mixing assembly 550, the ferrule 625 can beplaced inside the mixing assembly 550 and secured as a permanent orsemi-permanent fixture.

The features of the ferrule 625 are designed such that there are twoholes, and/or orifices and/or regions where fluid may enter and/or exitthe ferrule. In one embodiment there is one inlet and one outlet wherethe inlet is defined by the region where fluid will enter the powderpocket and come into contact with the powdered material and create amixed solution or partially-mixed solution. A mixed solution for thepurpose of this invention is defined to be at least one liquid componentand at least one powdered material that is partially mixed togetherand/or fully mixed together and/or where the powdered material ispartially dissolved in the liquid component and/or fully dissolved inthe liquid component. In another embodiment the liquid component can betwo liquids or more. In another embodiment the powdered material can betwo powdered materials or a blend of powdered materials.

The outlet of the ferrule is defined by a hole, or orifice, or regionwhere the mixed solution will pass out from the ferrule and into anotherchamber, i.e. the lower vial 614. In one embodiment the solution willpass out of the ferrule as a partially combined fluid and/or mixturewith the powder in the powder pocket. This mixed solution can exit theoutlet and fill another chamber directly. In another embodiment, thismixed solution can pass through to a second chamber by first travelingthrough a fluidic channel 621. In one embodiment, this channel can bestraight with a circular cross-section. In another embodiment thischannel can be straight with a non-circular cross-section. In anotherembodiment this channel can be non-straight with a circularcross-section. In another embodiment this channel can be non-straightwith a non-circular cross-section. In one embodiment, the channel canhave and or create bends or turns in the fluid path. In one embodimentthe fluid path can have a serpentine shape, or a spiral shape, or someother shape, for example, winding back-and-forth and/or have features,ridges or groves inside the channel, which creates a tortious path orsome combination of all previous embodiments.

In one embodiment, the fluid inlet hole can have a larger diameter thanthe fluid outlet hole. In another embodiment the fluid inlet hole canhave a larger cross-sectional area than the outlet hole. In anotherembodiment, the fluid inlet hole can be sized to be approximately thesame size as the fluid outlet hole. In one embodiment the side-wall ofthe ferrule can taper uniformly down to the fluid outlet hole. Inanother embodiments, the ferrule can include differing geometries wherethose geometries can be conical, hemispherical, or rectangular wedgeshaped. The sidewalls of the ferrule can be textured to increase orreduce powder-ferrule interfacial friction the help with powder fillingand potentially promote mixing of the liquid and powder inside theferrule.

In one embodiment the outlet hole of the ferrule can be covered by asealing structure or partially sealed structure which can be used toretain powdered material inside the powder pocket during a fillingoperation or during storage. In one embodiment this sealing structurecan also prevent fluid flow until the device was actuated which resultedin a change to the sealing structure, which would allow fluid to flowthrough the powder pocket.

In one embodiment, as illustrated, a sealing structure 610 can beprovided over the inlet of the ferrule but not the outlet. In oneembodiment there is a sealing structure over both the inlet and theoutlet. In some embodiment the ferrule can be formed from a softelastomer and the sealing structure is a small orifice that remainsconstricted until pressure from fluid flow forces the orifice to openand allows a partially mixed fluid of powder and solvent to flow.

The promotion of mixing inside the ferrule can come from the fluidresistance created by the outlet hole being smaller than the inlet holeforcing liquid to create eddies which fold back on themselves to causechaotic and/or turbulent flow by which the powder may mix fully and/ordissolve fully and/or mix partially and/or dissolve partially with theliquid entering the ferrule.

The ferrule can also be formed from metals and metal alloys (such asstainless steel), plastics (such as polypropylene, polyethylene, PEEK,COP, PET, PLA, etc), elastomeric materials (such as silicone, butylrubber, or chlorobutyl rubbers), materials such as glass, or othermaterials that are coated with a PTFE coating or some other coating.

In an embodiment, at least some of the mixing occurs in the ferrule.

In one embodiment, the promotion of mixing inside the ferrule can beincreased by structures inside the ferrule including but not limited toridges, grooves, bumps, herring-bone structures, and so forth that helpto create a tortious path.

In one embodiment, the powder is filled into a well and/or blisterand/or some other receiving region that holds the powder. In oneembodiment the powder is introduced into a holding region as a liquidand then lyophilized and/or vacuum dried and/or dried in some other wayinside the powder holding region.

In the illustrated embodiment, the fluidic channel 621 can be providedwith a mixing volume for retaining a dry medicament component prior tomixing with a wet component to form a wet medicament solution ormixture. In this embodiment, the fluidic channel 621 can be sized todefine a hollow volume corresponding in volume to the dry medicamentcomponent that is to be placed or received therein. As displayed, theupper vial 618 can be provided with selective fluidic communication,through the fluidic channel within the movable body 609, to the lowervial 614. In certain embodiments the movable body 609 can be formed ofmultiple parts. As illustrated the movable body 609 can be provided witha separate fluidic channel insert, or the fluidic channel can beunitarily formed within the movable body.

Once a wet component passes from the first chamber 618 and into thefluidic channel 621, it can then be received by the lower vial 614 andsubsequently passed through a needle 623 or other delivery assembly intothe injection site.

In yet additional embodiments the second chamber 614 can be configuredto carry or store a second medicament or component, wherein the firstchamber carries the first wet component to mix with the dry medicamentin the dry chamber (having a fluidic channel) disposed in the movablebody prior to mixing with the second wet component in the secondchamber.

In this embodiment, the system includes a needle assembly in fluidcommunication with the second chamber and a safety. The needle assemblyand the second chamber are selectively movable independently or as asingle unit relative to the housing. The system has a second actuationdevice that causes the needle assembly to be exposed or protrude fromthe housing and capable of injecting a wet medicament mixed in thefluidic channel. The safety is movable from a first safety position to asecond position prior to the activation of the actuation device.

In this embodiment of a drug delivery system the system can include ahousing having an extension component that is movable relative to thehousing and causing the effective length of the housing to have a largerdimension. The extension component may be a telescoping component, anunfolding component, re-attachable or other lengthening/widening typecomponent. In one embodiment, the extension component when activatedand/or lengthened allows the first actuation device to cause the movablebody to move into the first chamber. In one embodiment the extensioncomponent is attached to a removable sleeve that extends the injectorfully and then releases, or is ripped away from the auto injector.

While this embodiment can be normally stored in a compact state, it isready for activation upon a pulling action wherein the user pulls theframe extension cap 601 backwards and the needle shield 606 pops out ofthe device. This device design enables storage in a small footprint butextends during use, making it larger and thus easier and safer tohandle.

In this embodiment, the telescoping component, i.e. the frame extensioncap 601 moves laterally relative to the first housing in order toincrease the effective interior space of the housing

In the illustrated embodiment, the first chamber is collapsible, or inother words, the effective volume can be selectively reduced. In thisembodiment, the movement of the movable body 609 reduces the volume ofthe first chamber.

In the illustrated embodiment the mixing assembly 550 can incorporate avalve mechanism that opens the fluid path between the upper and lowervials thus allowing for a mixing between the wet and dry components.Mixing within this concept is initiated via a pulling of an extensioncap 601 relative to the outer housing 604. The pulling causes a rotationof an unlock ring 611 within the internal frame. The rotation of theunlock ring 611 causes an outward deflection of clip arms of the mixingspring clasp 622 until release of the mixing spring 619. The mixingspring 619 is coupled to the movable body 609, wherein release of energystored in the spring 619 results in an upward translation of the movablebody 609 into the upper vial 618 which simultaneously establishesfluidic communication between the upper and lower vials and allows formixing process that operates independently of user action onceinitiated.

The mixing process begins when the movable body 609, held in place bythe mixing spring clasp 622, is released. As the user pulls upwards onthe frame extension end cap 601, the frame extension cam 602 rotates theunlock ring 611. The unlock ring 611 has a ramped exterior surface whichinterferes with locking arms of the mixing spring clasp 622. theselocking arms are flexed outward by the rotation of the unlock ring 611until a clearance is established between a notch on the movable body 609and these locking arms. This clearance allows for the mixing spring 619to unload thus releasing the movable body 609 and causing it to travelupward into the upper vial 618.

The spring clasp 622 in one embodiment is envisioned to be constructedfrom stamped metal to avoid creep relaxation in plastic parts. In oneembodiment this part is to be made out of plastic and/or some othercomposite material, and possibly integrated into the outer housing 604or internal frame 603.

With the mixing spring 619 expanding, the movable body 609 movesupwards, initiating the mixing process contingent on some complianceeither in the upper vial 618, or in the movable body 609. It will beappreciated, as discussed above, that most fluids are incompressible, assuch a compressible substance or material is provided within, or incommunication with, the upper vial 618. In the embodiment shown, an airpocket 650 is provided within the upper vial 618 which can compress soas to allow relative translation of the movable body 609 into the uppervial 618 until fluidic communication is established and the fluid isallowed to travel into the lower vial 614.

It will be appreciated that while the present embodiments illustrate anopen air pocket 650 for allowing the movable body 609 to initially moveinto the upper vial 618 until fluidic communication is established, thatthe air pocket can also be contained within a compliant chamber using aflexible or compliant barrier in an upper portion of the vial, oralternatively upon the upper surface of the movable body 609 itself

As discussed above, the wet component is allowed to flow into theopening in an upper portion of when the opening clears the top edge ofthe upper seal 610. At this point, the wet component is flushed throughthe fluidic channel 621 and/or ferrule 625 through and down into thelower vial 614.

It will be appreciated that because the mixing process is triggered bythe release of the spring clasp 622 and the upward release of the mixingspring 619, that the mixing spring 619 is strong enough to compress theair pocket sufficiently to move the movable body 609 a sufficient degreeso as to establish fluidic communication, and then push the liquidcomponent through the fluidic channel 621 as well as expand the lowervial 614 sufficiently to receive the mixed drug and liquid.

Once the movable body 609 has fully depressed into the upper vial 618,thus reducing the effective volume of and pushing the fluid into thelower vial 614, the mixing assembly 550 is ready to deliver the mixedcomponents from the lower vial 614 through the needle 623.

The injection actuation is provided by initially extending and thenre-depressing the trigger/needle-shield 606, which as it isre-depressed, its upper arms cause an internal acutation, which asdiscussed below, will eventually release the injection spring 608. Therelease of the injection spring 608 is effectuated by the hanger stopretainer 607, wherein rotation of the rotating ring is effectuated by asubsequent depression of the needle shield 606 relative to the internalframe 603 and the mixing assembly 550.

The second actuation device involves the needle shield 606, which has apair of extended arms that extend into the internal frame 603 andinteract with the rotating hanger stop retainer 607. Depression of theneedle shield 606 after initial extension causes the rotating hangerstop retainer 607 to rotate the hanger stop 616 relative to the hanger617. In the illustrated embodiment, the second actuation device caninclude a pre-loaded spring which provides an injection force whichcauses the mixing assembly to be driven downward, abut against a bottomportion off the interior of the internal frame, thus causing the movablebody to compress into and reduce the effective volume of the lower vial614 and eject the mixed components through the delivery assembly.

The injection spring 608 itself is held in place by two pieces, theinner part of the hanger 617, connects to the lower face of the spring608, while the hanger stop 616 is locked to the upper portion of thespring via a keyed hole. By rotating the hanger 617 relative to thehanger stop 616, the spring is released. In one embodiment the hanger617 and the hanger stop 616 are made of resilient or spring steel. Inanother embodiment they are made of plastic or some other material. Therotating ring 607 can rotate, i.e. clockwise as shown, relative to thehanger stop 616, which is held rotationally via friction created by theinjection spring 608 and the hanger 617. A protrusion on the side of therotating hanger stop retainer 607 serves to receive a rotational forceas imparted by the needle shield arms which function as thetrigger/needle-shield 606 extends outward from the housing during themixing phase. After the needle shield 606 initially clears thisprotrusion, flexible beams return the hanger stop retainer 607 back toits original position, with the protrusion above the needle shield 606.The device is then armed as is signaled by the initial extension of theneedle shield 606.

In this position, the device is ready for activation upon re-depressionof the needle shield. As shown, the trigger/needle-shield 606 includes apair of arms having angled upper cam surfaces which are shaped in such away as to cause the rotating hanger stop retainer 607 to rotate inresponse to an axial re-depression of the needle shield 606, i.e. movecounter-clockwise as shown, moving the hanger stop 616) relative to thehanger 617. When the hanger stop 616 no longer interferes with thehanger 617, the injection spring 608 is released.

In the illustrated embodiment, the system can further include a needleassembly. The needle assembly and the second chamber 614 can be movableas one unit relative to the housing. The second actuation device causesthe needle assembly to be exposed or protrude from the housing andcapable of injecting a prepared drug that is disposed in the movablebody as described below.

As described above, as the hanger 617 released, the entire mixingassembly 550 is propelled downward through the internal frame 603. Asthe mixing assembly 550 is propelled downward by the injection spring608, the sterility barrier 615 is buckled and the needle 623 is insertedinto the user. The injection spring 608 continues extending after thelower vial 614 has contacted the bottom of the internal frame 603,moving the movable body 609, with upper vial 618, downwards through thelower vial 614, injecting the mixed component through the needle 623.

In some embodiments, the dry medicament is stored in the lower vial 614,which can be powder filled or lyophilized within the lower vial 614. Forthis embodiment a space or spacer would need to be included between thelower vial and the mixing spring in order to position the inner plungerat a sufficient distance away from the inner floor of the lower vial inorder to provide sufficient space/volume within which the dry medicamentmay be stored. This space enables some compression if needed. Structuresto improve reconstitution and mixing may be present in the lower vial.This may function as both an embodiment of the spacer and provideimproved mixing in the lower vial.

In one embodiment the trigger/needle-shield 606 doesn't extend and/ormake itself ready to be pressed until the mixing process has finished;preventing an incomplete mix from being delivered to the user. In orderto provide actuation the needle shield 606 can include a pair of snaparms which initially hold the needle shield in place relative to theinternal frame 603. In one embodiment, after mixing has been completed,and the movable body 609 has moved to the back of the upper vial 618,the needle shield snap arms are free to flex inwards since the movablebody 609 has moved sufficiently upward so as to provide clearance. Thisrequirement of clearance between the movable body 609 and the inwardflexion of the snap arms ensures that the trigger/needle-shield 606doesn't fully extend until the mixing process has completely finished;this introduces a failsafe mechanism to ensure safe use of the device.

After delivery is complete, the user simply removes the device and theneedle shield 606 extends, driven by the needle shield spring 605.Additionally, a lockout mechanism is envisioned in the internal frame603 which can consist of a snap, not shown, wherein the snap is deformedby the downward motion of the mixing assembly 550 during injection,wherein upon injection the snap engages an extension of the needleshield 606 and thus prevents any further movement of the needle-shield606 after it has been extended for the last time, hiding the needle.

In one embodiment, the mixing module can be assembled either in asterile environment or aseptically and sterilized afterwards using aterminal sterilization process. The mixing assembly 550 includes anupper vial 618, upper seal 610, mixing spring 619, unlocking ring 611,threaded mixing container 620, fluidic channel 621, mixing spring clasp622, mixing spring cover 613, lower vial 614, needle 623, and sterilitybarrier 615.

Additionally, a method of assembly is contemplated which includesvarious steps, which steps can include: Attaching the unlock ring 611and mixing spring clasp 622 to the mixing spring cover 613, then themovable body 609 and mixing spring 619 are loaded into this assembly bysnapping the spring clasp 622 in place. The lower vial 614 can be placedover the movable body 609 at this point, possibly at the same time asthe fluidic channel 621 which has been filled with the dry componentpreviously, is slid into the movable body 609. With this portion of themixing assembly being assembled, the upper vial 618, can then be filledwith the wet component and glued (or attached via other methods) to themixing spring cover 613. The upper seal 610 can then be attached andproperly placed by threading the threaded mixing container 620 into themixing spring cover 613. By adding the needle sterility barrier 615 tothis assembly, the mixing module is complete and can be handled innon-sterile environment, as the dry component, wet component, and needleare all sealed from the environment.

In one embodiment, the powder can be filled directly into the conicalshaped reservoir 625 (powder pocket) shown in FIGS. 13A-B. In anotherembodiment, the powder can be filled into a ferrule that, once filledwith powder, can then be placed inside the mixing assembly. In oneembodiment, the removable powder pocket can be filled either by tareingout a mass weight of the powder pocket and then filling using some typeof vibrational or auger filling tool or other volumetrically dosedmethods of measuring and transferring the dose to the mixing andinjection device. In another embodiment this powder pocket can be sizedappropriately and volumetrically filled. In another embodiment, thereservoir can be filled with a pre-formed, fast-dissolving powderstructure or lyophilized pellet. In another embodiment, the drug may belyophilized into the powder pocket directly.

In some embodiments the dry powder module can be provided as a separatecomponent from the movable body 609 in order to help facilitate fillingwith dry medicament and assembly. This also aids in allowing differentdrugs to be provided in various dosages so as to facilitate use in avariety of treatments and situations which is customizable to eachindividual drug application as well as each individual user's varyingdosage requirements.

In yet additional embodiments the powdered material can be provided as ablend of one or more therapeutic agents and at least onepharmaceutically acceptable excipient.

In some embodiments, the therapeutic agent can be provided as glucagon,sumatriptan, alprostadil, or other erectile dysfunction medications,diazepam or anti-seizure medications, anti-coagulants, medications fortramatic brain injury, or antichemical weapon antidones, depo-provera,or other fertility medications, or Pegvisomant, Etanercept, Adalimumab,Infliximab, Bevicuzumab, Rituximab, Trastuzumab, Insulin Glargine,Enoxaparin, Pegfilgrastim, Glatiramer, Ranibizumab, Epoetin alfa,Methotrexate, Golimumab, Certolizumab, Abatacept, Avonex, Betaferon,Extavia, Rebif, Fraxiparine, Darbepoetin alfa, Filgrastim, Follitropinalfa, Urofollitropin, Lutropin alfa, Follitropin beta, Belimumab,Denosumab, Atropine, Edrophonium, Pralidoxime, Lidocaine (amiodarone),Midazolam, Morphine, Novocaine (procaine hydrochloride), Codeine,Albuterol, Amitriptyline, Dexamethasone Phosphate, Benzodiazepine,Docusate Sodium, Fluoxetine, Haloperidol, Fluoxetine, Haloperidol,Lactulose, Loperamide, Metoclopramide,

In yet additional alternative embodiments the therapeutic agents caninclude Ondansetron, Hydrocortisone, Loratidine, Prednisolone, Cyanokit,Naloxone, Dimercaprol, Lorazepan, Phenobarbital, Cefazolin, ananti-inflammatory agent, anantimicrobial agent, an antifungal agent, ananti-parasitic agent, an anti-inflammatory agent, an anti-cancer agent,an agent for treatment of a cardiovascular disease, an agent fortreatment of an allergy reaction, or a pain-relieving agent. In someembodiments, the therapeutic agent is an agent for treatment of anallergy reaction. In some embodiments, the agent is for treatment ofanaphylaxis. In some embodiments, the agent is epinephrine.

Exemplified therapeutic agents include, but are not limited to,anti-inflammatory, antipyretic, anti-spasmodics or analgesics such asindomethacin, diclofenac, diclofenac sodium, codeine, ibuprofen,phenylbutazone, oxyphenbutazone, mepirizole, aspirin, ethenzamide,acetaminophen, aminopyrine, phenacetin, butylscopolamine bromide,morphine, etomidoline, pentazocine, fenoprofen calcium, naproxen,selecxip, valdecxip, and tolamadol, anti-rheumatism drugs such asetodolac, anti-tuberculoses drugs such as

isoniazide and ethambutol hydrochloride, cardiovascular drugs such asisosorbide dinitrate, nitroglycerin, nifedipine, barnidipinehydrochloride, nicardipine hydrochloride, dipyridamole, amrinone,indenolol hydrochloride, hydralazine hydrochloride, methyldopa,furosemide, spironolactone, guanethidine nitrate, reserpine, amosulalolhydrochloride, lisinopril, metoprolol, pilocarpine, and talcetin,antipsychotic drugs such as chlorpromazine hydrochloride, amitriptylinehydrochloride, nemonapride, haloperidol, moperone hydrochloride,perphenazine, diazepam, lorazepam, chlorodiazepoxide,

adinazolam, alprazolam, methylphenidate, myrnasipran, peroxetin,risperidone, and sodium valproate, anti-emetics such as metoclopramide,lamocetron hydrochloride, granisetron hydrochloride, ondansetronhydrochloride, and azacetron hydrochloride, antihistamines such aschlorpheniramine maleate and diphenhydramine hydrochloride, vitaminssuch as thiamine nitrate, tocopherol acetate, cycothiamine, pyridoxalphosphate, cobarnamide, ascortic acid, and nicotinamide, anti-gout drugssuch as allopurinol, colchicine, and probenecide, anti-Parkinson'sdisease drugs such as levodopa and selegrine, sedatives and hypnoticssuch as amobarbital, bromuralyl urea, midazolam, and chloral hydrate,antineoplastics such as fluorouracil, carmofur, acralvidinehydrochloride, cyclophosphamide, and thiodepa, anti-allergy drugs suchas pseudoephedrine and terfenadine, decongestants such asphenylpropanolamine and ephedorine, diabetes mellitus drugs such asacetohexamide, insulin, tolbutamide, desmopressin, and glipizide,diuretics such as hydrochlorothiazide, polythiazide, and triamterene,bronchodilators such as aminophylline, formoterol fumarate, andtheophylline, antitussives such as codeine phosphate, noscapine,dimorfan phosphate, and dextromethorphan, anti-arrhythmics such asquinidine nitrate, digitoxin, propafenone hydrochloride, andprocainamide, topical anesthetics such as ethyl aminobenzoate,lidocaine, and dibucaine hydrochloride, anticonvulsants such asphenyloin, ethosuximide, and primidone, synthetic glucocorticoids suchas hydrocortisone, prednisolone, triamcinolone, and betamethasone,antiulceratives such as famotidine, ranitidine hydrochloride,cimetidine, sucralfate, sulpiride, teprenone, plaunotol,5-aminosalicylic acid, sulfasalazine, omeprazole, and lansoprazol,central nervous system drugs such as indeloxazine, idebenone, thiapridehydrochloride, bifemelane hydrocide, and calcium homopantothenate,antihyperlipoproteinemics such as pravastatin sodium, simvastatin,lovastatin, and atorvastatin, antibiotics such as ampicillinhydrochloride, phthalylsulfacetamide, cefotetan, and josamycin, BPHtherapeutic agents such as tamsulosin hydrochloride, doxazosin mesylate,and terazosin hydrochloride, drugs affecting uterine motility such asbranylcast, zafylcast, albuterol, ambroxol, budesonide, and reproterol,peripheral circulation improvers of prostaglandin I derivatives such asberaprost sodium, anticoagulants, hypotensives, agents for treatment ofcardiac insufficiency, agents used to treat the various complications ofdiabetes, peptic ulcer therapeutic agents, skin ulcer therapeuticagents, agents used to treat hyperlipemia, tocolytics, etc.

In yet additional embodiments the housing can be provided with a shroud,not shown, which initially covers the injection end of the auto injectorand is selectively coupled to the housing, such that during the initialactivation and mixing steps of extending the telescoping component theneedle shield can be covered so as to prevent a user from being able tounintentionally cause a premature injection. The shroud can beinterferingly engaged with the housing over the injection end whereinthe extension of the telescoping component and a signaling of acompletion of the mixing step also unlocks the shroud and allows it tobe removed from the housing, thus allowing for initial extension of theneedle shield and associated arming of the needle shield as the secondinjection step trigger.

While the principles of the invention have been described herein, it isto be understood by those skilled in the art that this description ismade only by way of example and not as a limitation as to the scope ofthe invention. Other embodiments are contemplated within the scope ofthe present invention in addition to the exemplary embodiments shown anddescribed herein. Modifications and substitutions by one of ordinaryskill in the art are considered to be within the scope of the presentinvention. Additionally, any features, structures, components, methodsteps which are discussed in reference to any one of the aforementionedembodiments are readily adaptable for use into and with any features ofthe other alternative embodiments discussed therein, with theunderstanding that one of ordinary skill in the art will be capable ofassessing the ability and be capable of making such adaptations.

What is claimed:
 1. A medication mixing and delivery device comprising:a housing; a first chamber, a second chamber, and a compression chamberlocated within the housing, wherein each chamber has a selectivelychangeable effective volume; a fluidic channel disposed between thefirst chamber and the second chamber; a seal positioned between thefirst chamber and the compression chamber; a movable body disposedbetween the first chamber and the second chamber; a mixing actuationdevice coupled to the movable body, wherein activation of the mixingactuation device facilitates: the selective reduction of the effectivevolume of the first chamber; the selective reduction of the effectivevolume of the compression chamber; and displacement of a liquid storedin the first chamber from the first chamber into the second chamber viathe fluidic channel; a delivery assembly configured to be in fluidcommunication with the second chamber; and a mixing spring coupled tothe mixing actuation device, wherein the mixing spring initially storesa torsional force and a compression force in torsion and compression,and whereupon an activation of the mixing actuation device results in arelease of the torsional force and the compression force of the spring.2. The medication mixing and delivery device of claim of 1, furtherincluding a delivery actuation device coupled to the movable body, andwherein prior to activating the delivery actuation device the mixingspring is re-torqued.
 3. The medication mixing and delivery device ofclaim of 1, wherein the torsional force released is directed to androtates the movable body about an axis.
 4. A method for mixing anddelivering a medication, the method comprising: activating a mixingactuation device of a medication mixing and delivery device thattranslates a movable body, wherein the medication mixing and deliverydevice is comprised of: a housing; a first chamber, a second chamber anda compression chamber located within the housing, wherein each chamberhas a selectively changeable effective volume; a fluidic channeldisposed between the first chamber and the second chamber; a sealpositioned between the first chamber and the compression chamber; themovable body disposed between the first chamber and the second chamber,the movable body being coupled to a mixing displacement mechanism; themixing actuation device coupled to the movable body; and a deliveryassembly configured to be in fluid communication with the secondchamber; releasing a torsional and compression force stored in a mixingspring that is coupled to the mixing actuation device, wherein thecompression force from the mixing spring provides energy for the movablebody to translate toward the seal; displacing the effective volume ofthe compression chamber by causing the mixing displacement mechanismcoupled to the movable body to translate toward the dynamic seal;displacing a liquid stored in the first chamber through the fluidicchannel into the second chamber; and displacing the liquid now stowed inthe second chamber through the delivery device.
 5. The method for mixingand delivering a medication of claim 4, wherein the released torsionalforce acts on and causes the movable body to rotate about an axis. 6.The method for mixing and delivering a medication of claim 4, furthercomprising the step of arming a delivery actuation device uponactivation of the mixing actuation device by re-torqueing the mixingspring prior to displacing the liquid now stowed in the second chamber.7. A medication mixing and delivery device comprising: a housing; afirst chamber and a second chamber located within the housing, whereineach chamber has a selectively changeable effective volume; a fluidicchannel disposed between the first chamber and the second chamber; amovable body disposed between the first chamber and the second chamber;a mixing actuation assembly coupled to the movable body and a mixingspring, wherein activation of the mixing actuation device facilitates: arotation and translation of the movable body about an axis; a selectivereduction of the effective volume of the first chamber, and atransferring of liquid stored in the first chamber to be displaced fromthe first chamber and enter into the second chamber via the fluidicchannel; and a delivery assembly configured to be in fluid communicationwith the second chamber.
 8. The medication mixing and delivery device ofclaim 7, further comprising a torqueing component configured to causetorsion in the mixing spring during the actuation of the mixingactuation assembly.
 9. The medication mixing and delivery device ofclaim 7, further comprising a compression chamber separated from thefirst chamber by a dynamic seal.
 10. The medication mixing and deliverydevice of claim 7, further comprising a delivery actuation assemblyconfigured to transfer fluid from the second chamber through thedelivery assembly.
 11. The medication mixing and delivery device ofclaim 10, wherein the delivery actuation is coupled to an extendabletrigger, whereupon triggering the extendable trigger causes the deliveryactuation assembly to actuate.
 12. The medication mixing and deliverydevice of claim 11, wherein the mixing actuation assembly is coupled tothe extendable trigger, and causes a portion of the extendable triggerto be extended during actuation of the mixing actuation assembly. 13.The medication mixing and delivery device of claim 12, whereintriggering the extendable trigger causes the mixing spring to release atorsional force.
 14. The medication mixing and delivery device of claim13, wherein the torsional force causes the movable body to rotate. 15.The medication mixing and delivery device of claim 12, wherein theextendable trigger forms part of a needle shield assembly.
 16. Themedication mixing and delivery device of claim of claim 15, whereupondepressing the extendable trigger causes energy from a pre-loaded needleassembly energy source to be released and directed towards extending aportion of the needle shield assembly to extend beyond the deliveryassembly once the extendable trigger is released.
 17. The medicationmixing and delivery device of claim of 16, further including a lockingmechanism that prevents the extended needle shield assembly fromretracting after being extended beyond the delivery assembly.
 18. Themedication mixing and delivery device of claim 8, wherein the torqueingcomponent is a multi-cam system.
 19. A method for mixing and deliveringa medication, the method comprising: releasing energy stored in apre-torqued and pre-compressed mixing spring, wherein the release ofenergy causes a movable body, disposed between a first and secondchamber disposed in the housing of a mixing device, to rotate andtranslate about an axis; displacing an effective volume of the firstchamber with a displacement device coupled to the movable body;transferring a fluid stored in the first chamber through a fluidicchannel to the second chamber; re-torqueing the mixing spring; releasingenergy from the re-torqued spring that causes the movable body to rotateagain; and transferring fluid from a second chamber through a deliveryassembly.
 20. The method for mixing and delivering a medication of claim19, further comprising a delivery system coupled to the mixing device,wherein the delivery system includes a delivery actuation assemblycoupled to the movable body.
 21. The method for mixing and delivering amedication of claim 20, further including the step of extending atrigger coupled to the delivery actuation assembly.
 22. The method formixing and delivering a medication of claim 20, further including thestep of activating a trigger coupled to the delivery actuation assembly.23. The method for mixing and delivering a medication of claim 22,further including depressing the trigger, whereby energy is releasedfrom a delivery spring that causes the delivery actuation device totranslate the movable body.